Recall Z-2613-2025 ยท OWQ Reprocessed Intravascular Ultrasound Catheter
Medline Industries, LP
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
| Date | Sep 26, 2025 (initiated Jul 31, 2025) |
| Status | Open, Classified |
| Reason | Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. |
| Root cause | Under Investigation by firm |
| Action | On July 31, 2025, the firm notified customers via first class mail and email of the potential product issue. An updated letter was sent to customers on 8/13/25 with additional item and lot numbers. Affected products are to be returned for credit. Customers were instructed to immediately identify and quarantine all affected product within their possession. Once they have completed and returned the response form listing their affected inventory, they will receive return labels and RGA information. Customers will receive credit when the returned product is received. |
| Quantity | 7913 eaches |
| Distribution | Domestic US distribution nationwide. International distribution pending. No international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter Surgical Instrument Services and Savings, Inc., Dec 15, 2023 |